510(k) K953071

STRYKER COMMAND2 OFFICE CONSOLE by Stryker Instruments — Product Code JEA

K953071 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "STRYKER COMMAND2 OFFICE CONSOLE". The FDA issued a decision of Substantially Equivalent on August 8, 1995. The device falls under product code JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Stryker Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1995
Date Received
June 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Surgical With Orthopedic Accessories, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type